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Postoperative Symptoms Following Endodontic Microsurgery

Primary Purpose

Pain Postoperative, Swelling Lips & Face

Status
Recruiting
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
Endodontic Microsurgery
Sponsored by
King Abdullah University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain Postoperative focused on measuring Microsurgery, Pain, swelling, Piezo surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Non-smokers . Teeth that are periodontally healthy. Age (18-65) Exclusion Criteria: Patients with an active systematic diseases that may affect the outcome Medically compromised patients on long term medications. Patients who had received analgesics or antibiotics prior to surgery will be postponed. Cases where orthograde endodontic treatment is feasible Teeth with poor prognosis. Teeth with an active periodontal disease (pocket depth > 5 mm). Emotionally distressed patients.

Sites / Locations

  • Jordan University of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Piezo endodontic surgery

Conventional endodontic surgery

Arm Description

The osteotomy will be applied under magnification with a surgical operating microscope (at the apical third of the root .Osteotomy will be done with the Piezosurgery touch

The osteotomy will be applied under magnification with a surgical operating microscope at the apical third of the root .Osteotomy will be done with air motor high speed hand-piece and round bur with copious irrigation

Outcomes

Primary Outcome Measures

changes in pain severity
visual analogue scale that is calibrated between (no discomfort ) and end with (very server pain ),
Swelling size changes
Changes in amount of swelling will be measured by measuring distance between fixed points in patient face.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2023
Last Updated
June 7, 2023
Sponsor
King Abdullah University Hospital
Collaborators
Jordan University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT05898035
Brief Title
Postoperative Symptoms Following Endodontic Microsurgery
Official Title
Postoperative Symptoms Following Endodontic Microsurgery Performed by Piezoelectric Osteotomy Versus Conventional Osteotomy: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdullah University Hospital
Collaborators
Jordan University of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Aims: The purpose of this randomized clinical trial is to assess and compare the post operative pain, swelling and quality of life after endodontic microsurgery using either conventional osteotomy or piezoelectric osteotomy . The PICO question that will be used is Does endodontic microsurgery using piezoelectric osteotomy have similar clinical performance in terms of post operative pain and swelling to that of endodontic microsurgery using conventional hand-piece osteotomy. Material and methods: based on solid inclusion criteria , a total of 44 patients in need of endodontic microsurgery will be randomly distributed into two groups (n=22) according to the osteotomy technique: conventional and piezoelectric osteotomy. A standardized microsurgical technique will be employed. After the microsurgery procedure, a pain questionnaire that contain visual analogue scale will be given to each patient to evaluate the pain incidence and intensity at 5 time intervals, 24 hours, 48 hours, 72 hours, 96 hours and 120 hours. The patients will be recalled as well, at days 2 and 7 to evaluate the swelling. Statistical analysis will be performed using chi-square test and linear regression analysis.
Detailed Description
This randomized prospective clinical study will be conducted at the postgraduate clinics, Department of Conservative Dentistry, at Jordan University of Science and Technology. Ethical approval will be sought from the JUST Institutional ethics and human Research Board (IRB) committee. Sample size and randomization A total of 44 adult patients will be recruited for this clinical trial. Participants will be randomly allocated to one of the two treatment modalities. Randomization will be carried out by sealed envelope online software. For the observational part of the study, no randomization or blinding will be applied. Patients will be treated free of charge and their travel expenses will be compensated for all follow up visits. Preoperative management : Clinical and radiographic assessment : - The patient demographic information, chief complaint and history of the chief complaint, medical and dental history will be registered. A thorough extra-oral and intra-oral examination will be undertaken (an existing swelling , sinus tracts, quality of coronal restoration margins and its history, occlusal relations, gingival biotype , any gingival recession and periodontal assessment ) will be registered . Percussion and palpating tests will be applied. Pre-operative parallel Digital view will be obtained using film holder showing the entire lesion and at least 2 mm beyond it. Limited view cone beam computed tomography scan of the diseased tooth will be obtained for each patient preoperatively (SFV). Root length and axis, Lesion size and features, bone crest level and any radiographic abnormality will be interpreted and registered. All patients will receive periodontal scaling a week or two before the surgery. Surgical procedure Prior to surgery , patients will be asked to rinse their mouth with chlorhexidine 0.12% . After which, local anesthesia containing epinephrine will be given. The surgical flap design and procedure will be selected as per case deem , and the flap will be elevated gently and retracted. The Root apex will be located and osteotomy will be applied. The resected root will be rinsed , dried and and stained with 1% methylene blue dye after which , it will be inspected carefully under high magnification, to identify possible reasons for the non surgical root canal treatment failure. Subsequently, ultrasonic apical preparation will be performed. After achieving adequate haemostasis with Epinephrine pellets (Gingi-Pak , California state , USA),Biodentine retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament size 5-0 suture will be applied. Finally, Post-operative parallel Digital view will be obtained using film holder showing the entire lesion and at least 2 mm beyond it. Post-operative management : Immediately after the microsurgery the patients will be asked to apply cold ice packs on the surgical site for 20 mins at the clinic, during this time the post-operative instructions will be given .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Postoperative, Swelling Lips & Face
Keywords
Microsurgery, Pain, swelling, Piezo surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This a randomized prospective clinical study
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Piezo endodontic surgery
Arm Type
Experimental
Arm Description
The osteotomy will be applied under magnification with a surgical operating microscope (at the apical third of the root .Osteotomy will be done with the Piezosurgery touch
Arm Title
Conventional endodontic surgery
Arm Type
Active Comparator
Arm Description
The osteotomy will be applied under magnification with a surgical operating microscope at the apical third of the root .Osteotomy will be done with air motor high speed hand-piece and round bur with copious irrigation
Intervention Type
Procedure
Intervention Name(s)
Endodontic Microsurgery
Intervention Description
Osteotomy will be done either with air motor high speed hand-piece and round bur with copious irrigation or with Piezosurgery touch. After the soft tissue curettage and uncovering the root apex , the last 3 mm of the root apex will be resected perpendicular to the long axis of the tooth at ( 0 - 10) degree bevel , using either conventional dental hand-piece or piezotome (Piezotome Cube by ACTEON ).The resected root will be rinsed , dried and and stained with 1% methylene blue dye after which , it will be inspected carefully under high magnification, to identify possible reasons for the non surgical root canal treatment failure. Subsequently, ultrasonic apical preparation will be performed. After achieving adequate haemostasis with Epinephrine pellets. Biodentine®retrograde filling material will be placed. The flap will be re-approximated and interrupted suture using non-absorbable monofilament size 5-0 suture will be applied. Finally, Post-operative parallel Digital view.
Primary Outcome Measure Information:
Title
changes in pain severity
Description
visual analogue scale that is calibrated between (no discomfort ) and end with (very server pain ),
Time Frame
to measure changes in the pain severity at 3 hours, 24 hours , 48 hours , 72 hours and 120 hours.
Title
Swelling size changes
Description
Changes in amount of swelling will be measured by measuring distance between fixed points in patient face.
Time Frame
At the second and seventh days after the microsurgery, patients will be re-called for the determination of edema and swelling

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Non-smokers . Teeth that are periodontally healthy. Age (18-65) Exclusion Criteria: Patients with an active systematic diseases that may affect the outcome Medically compromised patients on long term medications. Patients who had received analgesics or antibiotics prior to surgery will be postponed. Cases where orthograde endodontic treatment is feasible Teeth with poor prognosis. Teeth with an active periodontal disease (pocket depth > 5 mm). Emotionally distressed patients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lama A Awawdeh, PhD
Phone
+962795412954
Email
lawawdeh@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lama A Awawdeh, PhD
Organizational Affiliation
Jordan University of Science and Technolgoy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jordan University of Science and Technology
City
Irbid
ZIP/Postal Code
POBOX 3030
Country
Jordan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lama A Awawdeh
Phone
0795412954
Email
lawawdeh@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Postoperative Symptoms Following Endodontic Microsurgery

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